Outsourced Activities: How to Manage them

Your Outsourced Third-Party Services and Providers

Outsourcing is a common practice in the pharmaceutical industry, where companies may delegate some of their activities to third-party service providers. These activities may include transport, storage, cleaning, security and more. 

Outsourcing can offer many benefits, such as cost reduction, efficiency improvement, and access to specialized expertise. However, outsourcing can also pose challenges and increase risks if you select poorly or do not fully understand the activity you plan to outsource.

To ensure that outsourced activities are performed in accordance with good distribution practice (GDP), there are some key steps that need to be followed. These steps are based on the guidelines of the European Commission on GDP of medicinal products for human use, which apply to all parties involved in the distribution chain of medicinal products in the European Union.

1. Define the scope and requirements of the outsourced activity

Before outsourcing any activity, it is important to clearly define the scope and requirements of the activity, such as the objectives, deliverables, timelines, standards, and performance indicators. This will help to identify the best service provider for the task and to avoid any misunderstandings or conflicts later on.

2. Select a qualified and reputable service provider

The selection of a service provider should be based on a thorough assessment of their capabilities, qualifications, experience, reputation, and compliance with GDP. This may involve conducting background checks, verifying references, reviewing certificates and licenses, and performing audits or inspections. The service provider should also demonstrate their commitment to quality management and continuous improvement.

3. Establish a written contract or agreement

A written contract or agreement is essential for defining and regulating the relationship between the contract giver and the contract acceptor. The contract or agreement should clearly specify the roles and responsibilities of each party, the scope and requirements of the outsourced activity, the terms and conditions of payment and delivery, the quality standards and procedures, the reporting and communication mechanisms, the risk management and contingency plans, and the dispute resolution and termination clauses. The contract or agreement should be signed by both parties and reviewed periodically.

4. Monitor and review the performance of the service provider

The contract giver should monitor and review the performance of the service provider on a regular basis to ensure that they are meeting the expectations and requirements of the outsourced activity.

This may involve collecting and analyzing data, conducting audits or inspections, obtaining feedback from customers or stakeholders, and identifying any issues or problems.

The contract giver should also provide feedback and guidance to the service provider to help them improve their performance and quality.

5. Implement corrective and preventive actions if needed

If any issues or problems are detected during the monitoring and review process, the contract giver should implement corrective and preventive actions to resolve them as soon as possible.

This may involve communicating with the service provider, requesting corrective actions or improvements, imposing sanctions or penalties, or terminating the contract or agreement if necessary. The contract giver should also document and record all actions taken and their outcomes.

Outsourcing can be a valuable strategy for enhancing the efficiency and effectiveness of pharmaceutical distribution.

However, it also requires careful planning, management, and control to ensure that outsourced activities are performed in accordance with GDP. By following these steps, companies can ensure that they outsource their activities in a responsible and compliant manner.

It is a regulatory requirement that you and your staff at all levels throughout the company receive GDP Guidelines training, before engaging the tasks and procedures involved within the registered and licensed premises.

 Training, Support and Assistance

Paradigm Shift Consulting Ltd offer a comprehensive range of courses designed to address all possible aspects of GDP operations. We run an online GDP Webinar for RPs and Management every month, with a thorough training schedule covering all 10 chapters of the EU guidelines complete with vivid examples of how things can go wrong and of course outsourced activities, and what you must do to remain within compliance.

If you wish to know more, call us for a free 5 minute consultation, or you can use the contact form below. Alternatively, email us at info@paradigmshiftconsulting.co.uk if your requirements or issues are more complex.

A list of posts and links associated with this topic are shown below.

EU GDP Guidelines (2013/C 343/01)  Chapter 1 section 3

MHRA Blog: Responsibilities of MAHs

Contracts for Outsourced Activities

Approval of Suppliers and Customers

Bona Fide Checks: An Update